BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BARD MONOFILAMENT POLYPROPYLENE HERNIA 2" X 4"

    MDR report key: 8565152 · Received April 29, 2019

    Report

    Report Number
    MW5086262
    Event Type
    Injury
    Date Received
    April 29, 2019
    Date of Event
    December 10, 2017
    Report Date
    April 21, 2019
    Manufacturer
    DAVOL INC., SUB C. R. BARD, INC.
    Product Code
    FTL
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I WAS INFORMED THAT THE BARD MESH USED IN MY HERNIA REPAIR IS MADE OF POLYPROPYLENE AND IS NOT TO BE USED IN THE HUMAN BODY AND WITH MY LONG TERM (B)(6) DIAGNOSIS THAT THE MESH USED IS TOXIC TO PEOPLE WITH COMPROMISED IMMUNE SYSTEMS. AFTER BEING INFORMED OF THIS KNOWLEDGE I HAVE BEEN LIVING WITH ANXIETY DAILY CAUSING SLEEP PROBLEMS AND A LOT MORE, I DAILY LIVE WITH THE FEAR THAT MY MEDICATIONS TO STAY ALIVE TO TREAT (B)(6) WILL CAUSE AN AUTOIMMUNE RESPONSE DUE TO THE USE OF A POLYPROPYLENE MESH THAT THE MSDS SHEET CLEARLY STATES NOT TO BE USED IN HUMANS. ANXIETY, NAUSEA DAILY. DATE OF USE: (B)(6) 2017. REASON FOR USE: HERNIA. DID THE PROBLEM STOP AFTER THE PERSON REDUCED THE DOSE OR USING OR TAKING THE PRODUCT? NO; DID THE PROBLEM RETURN IF THE PERSON STARTED TAKING OR USING THE PRODUCT AGAIN? NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    356438 BARD MONOFILAMENT POLYPROPYLENE HERNIA 2" X 4" MESH, SURGICAL POLYMERIC FTL DAVOL INC., SUB C. R. BARD, INC. HUAX0846

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Life Threatening ATAZANAVIR SULFATE 300 MG | NORVIR 100MG| ONDANSETRON 4MG| TRUVADA 200MG/300MG